NIACIN - Generic Drug Details

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What are the generic sources for niacin and what is the scope of freedom to operate?

Niacin is the generic ingredient in seven branded drugs marketed by Medpointe Pharm Hlc, Amneal Pharms, Aurobindo Pharma Ltd, Barr, Beijing, Chartwell Rx, Hibrow Hlthcare, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Rising, Sun Pharm, Yichang Humanwell, Abbvie, Everylife, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mk Labs, Purepac Pharm, Sandoz, Tablicaps, Watson Labs, Wockhardt, Avondale Pharms, Sanofi Aventis Us, and Intl Minerals, and is included in thirty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for niacin. Eleven suppliers are listed for this compound.

Summary for NIACIN

US Patents:	0
Tradenames:	7
Applicants:	28
NDAs:	35
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	211
Clinical Trials:	171
Patent Applications:	7,089
Drug Prices:	Drug price trends for NIACIN
Drug Sales Revenues:	Drug sales revenues for NIACIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NIACIN
What excipients (inactive ingredients) are in NIACIN?	NIACIN excipients list
DailyMed Link:	NIACIN at DailyMed

See drug prices for NIACIN

See drug sales revenues for NIACIN

Recent Clinical Trials for NIACIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval	N/A
Centre de recherche du Centre hospitalier universitaire de Sherbrooke	N/A
Rhode Island Hospital	Early Phase 1

See all NIACIN clinical trials

Pharmacology for NIACIN

Drug Class	Nicotinic Acid

Medical Subject Heading (MeSH) Categories for NIACIN

Hypolipidemic Agents
Vasodilator Agents
Vitamin B Complex

US Patents and Regulatory Information for NIACIN

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	090860-001	Mar 20, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hibrow Hlthcare	NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	213090-003	Aug 25, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Yichang Humanwell	NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	212017-001	Jun 10, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-002	Jul 28, 1997		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for NIACIN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NIASPAN TITRATION STARTER PACK	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-005	Jul 28, 1997	⤷ Sign Up	⤷ Sign Up
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-004	Jul 28, 1997	⤷ Sign Up	⤷ Sign Up
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-003	Jul 28, 1997	⤷ Sign Up	⤷ Sign Up
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-003	Jul 28, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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